Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0606-03

External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A

Integra LifeSciences Corporation / initiated 2002-12-16 / Terminated

Integra LifeSciences Corp began a recall of External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A on . The reason FDA records is "The check valve in the patient line may stick in the closed position". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0606-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Integra LifeSciences Corporation
Product
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
Product code
LID
Reason for recall
The check valve in the patient line may stick in the closed position.
FDA root cause
Other
Action
Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.
Quantity in commerce
8952
Distribution
The affected products have been distributed to hospitals, distributors, and Integra Sales Representatives. There are 202 direct hospital customers, 5 foreign distributors, and 1 wholesaler. Government distribution include the National Institute of Health in Bethesda, MD and 9 Veterans Administration Hospitals. International distributions to the following countries: United Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, Gabron, United Kingdom, Greece, Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Sweden, Turkey, South Africa, and Mexico.
Product codes and lots
The External Drainage Sets lot numbers: 60300370, 60306608, 60306609, 60321387, 60300373, and 60376191. These lots of EDS may be included in the following set configurations:  Catalog #: 910-109 Lot#: 0118080; 0118369; 0118572; 0118981; 0119845; 0117525.  Catalog# 910-110A Lot #: 60300370; 60300373; 60306608; 60300370-1; 60321387; 60306608-1; 60306609; 60321387-1; 60306609-1; 60321387-2; 60376191; 60321387-3.  Catalog# 910-112A Lot #: 0117569; 0117609; 0117834; 0117478; 0117833; 0117957; 0118062; 0118175; 0118420; 0118421; 0118573; 0118693.  Catalog #910-118A Lot#: 0117570; 0117479; 0118023; 0118489; 0119150; 0119505.  Catalog #910-120A Lot #: 0117536; 0117371; 0117453; 0117537; 0117902; 0117948; 0118047; 0118161; 0118422; 0118543; 0118616; 0118744; 0118808; 0118912; 0118955; 0119020; 0119081; 0119348; 0119500; 0119582.  Catalog #910-123A Lot #: 0117805; 0118576; 0118845; 0118957.